Sensor-controlled digital game for heart failure self-management behavior adherence: A randomized controlled trial

项目摘要/摘要 心力衰竭(HF)是一种日益流行的疾病；在美国，被诊断为HF的人数预计将 到2030年增加到800万，年成本为690亿美元。尽管采取了有效的干预措施来降低心力衰竭的发病率 和死亡率，心力衰竭弱势人群的住院和死亡率不成比例 尤其是在美国南部各州。改善心力衰竭的自我管理(SM)行为干预 因此，结果势在必行。促进SM行为的远程干预是一个重要的 应对心力衰竭结果中日益扩大的地域和种族健康差距的战略。一件有希望的事 方法是使用传感器控制的数字游戏(SCDG)，它提供负担得起的、便携的、可扩展的工具 促进参与表现出最差依从性的HF SM行为(体重监测和身体检查 活动)，同时令人愉快且易于使用。这项研究的主要目标是评估一种 SCDG干预，整合了心力衰竭参与者来自体重秤和活动跟踪器的行为数据 用于激活游戏进度、奖励和反馈的传感器。对于目标1，我们将细化我们已有的SCDG 已经为移动智能手机开发，可以玩更长时间的游戏，以实现持续行为 坚持体重监测和体力活动。对于目标2，使用随机对照临床试验，我们 将SCDG干预与仅传感器干预的主要结果进行比较 参与高频SM的体重监测行为与体力活动的次要结果 行为投入、心力衰竭管理知识、自我效能、心力衰竭功能状态、住院治疗和生活质量 在基线、6周、12周和24周。对于我们的样本，我们将从7岁开始招募45岁或以上的成年人 在过去的6个月里，他因感染心力衰竭而住院。我们将随机选择200名参与者 或者是SCDG干预组，在干预组中，参与者将接受跟踪体重监测的传感器和 活动，并将在移动智能手机上播放SCDG，或将接收传感器、应用程序的控制组 它跟踪活动和体重监测，并标准化的HF书面教材。对于目标3，我们 将进行混合方法评估，以识别影响参与者的 参与基于传感器的干预，以确保高频SM行为的一致性。对于目标4，基于每日高频 SM体重监测和体力活动行为数据和生态瞬时评估 症状、情绪、满意度和认知状态，我们将对HF SM体重进行数字表型- 监测和体力活动行为。该项目将为可扩展和 易于使用的数字游戏解决方案，以激励对HF SM行为的持续遵守并改善健康 心力衰竭患者的预后。

PROJECT SUMMARY/ABSTRACT Heart failure (HF) is a growing pandemic; in the U.S., the number of those diagnosed with HF is expected to rise to 8 million with annual costs at $69 billion by 2030. Despite effective interventions to reduce HF morbidity and mortality, vulnerable populations with HF suffer disproportionately from hospitalization and mortality especially in the southern U.S. states. Self-management (SM) behavioral interventions to improve HF outcomes are therefore imperative. Remote interventions to promote SM behaviors present an important strategy to address the widening geographical and racial health disparities in HF outcomes. One promising approach is the use of sensor-controlled digital games (SCDGs), which offer affordable, portable, scalable tools to facilitate engagement in HF SM behaviors that show the poorest adherence (weight monitoring and physical activity) while being enjoyable and easy to use. The primary goal of this study is to evaluate the efficacy of a SCDG intervention that integrates HF participants’ behavioral data from weight scale and activity tracker sensors to activate game progress, rewards, and feedback. For Aim 1, we will refine an SCDG that we have already developed for mobile smartphones to be playable for longer durations for sustained behavior adherence to weight-monitoring and physical activity. For Aim 2, using a randomized controlled clinical trial, we will compare the SCDG intervention versus a sensor-only intervention for the primary outcome of rate of engagement in the HF SM behavior of weight-monitoring and the secondary outcomes of physical activity behavior engagement, HF SM knowledge, self-efficacy, HF functional status, hospitalization, and quality of life at baseline and at 6, 12, and 24 weeks. For our sample, we will recruit adults aged 45 years or older from 7 southern U.S. states and hospitalized with HF within the past 6 months. We will randomize 200 participants to either the SCDG intervention group, in which participants will receive sensors that track weight monitoring and activity and will play the SCDG on a mobile smartphone, or a control group that will receive sensors, an app that tracks activity and weight monitoring, and standardized written HF educational materials. For Aim 3, we will conduct a mixed-methods assessment to discern facilitators and barriers impacting participants’ engagement with the sensor-based interventions for HF SM behavior adherence. For Aim 4, based on daily HF SM weight-monitoring and physical activity behavior data and ecological momentary assessments of symptoms, mood, satisfaction, and cognitive status, we will conduct digital phenotyping of HF SM weight- monitoring and physical activity behaviors. This project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF SM behaviors and improve health outcomes among individuals with HF.